ADCETRIS is a CD30-directed antibody-drug conjugate indicated for treatment of patients with: • Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. • Systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen. Accelerated approval was granted for the above indications based on overall response rate. An improvement in patient-reported outcomes or survival has not been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
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In August 2011, the U.S. FDA granted accelerated approval to the biologics license application (BLA) submitted by Seattle Genetics for the use of brentuximab vedotin in the treatment of relapsed HL and ALCL. In March 2018, the FDA granted an expansion of use to include first-line treatment of stage III and IV HL in combination with chemotherapy. In October 2012, the European Medicines Agency (EMA) gave it conditional marketing authorization for relapsed or refractory HL and ALCL. In November 2017, the FDA approved brentuximab vedotin as a treatment for patients with cutaneous T-cell lymphoma (CTCL) who have received prior systemic therapy. This approval is for patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF).
ADCETRIS® (brentuximab vedotin) for injection, for intravenous use. Initial U.S. approval: 2011
Generic Name: brentuximab vedotin
For injection: 50 mg lyophilized powder in a single-use vial
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For overseas patients, ADCETRIS (brentuximab vedotin) can be made available in Send your enquiry to find ADCETRIS (brentuximab vedotin) in China, Cambodia, Indonesia, Malaysia, the Philippines, Singapore, Thailand, Vietnam, Hong Kong. UAE Iraq, Iran, Saudi Arabia, Jordan, Mexico, Argentina, Brazil, Chile, Colombia, Peru, Venezuela. Europe – Romania, Switzerland, Georgia, Turkey, Italy, UK, Ukraine, Azerbaijan, Latvia, Poland, Slovakia. Russia CIS – Armenia, Kazakhstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan, Mongolia, Algeria, Mauritius, Uganda, Zimbabwe. Australia and New Zealand.
Seattle Genetics Announces Health Canada Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma For More Details
Seattle Genetics (SGEN) Reports Health Canada Approval of ADCETRIS (Brentuximab Vedotin) in Combination with Chemotherapy For More Details